CRA II
Hybrid · Osaka, Osaka, Japan or Tokyo, Tokyo, Japan
Job Summary
Site qualification, initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) with emphasis on regulatory/ICH-GCP/GPP compliance; perform Source Document Review, ensure accurate data capture in CRFs, and maintain ISF/TMF accuracy; train and guide site staff; support patient recruitment/retention; coordinate with sponsor and project teams; adapt to changing priorities and travel up to 75% across study sites; leverage SOPs and regulatory knowledge to ensure audit readiness and data integrity; for Real World Late Phase, operate as Site Management Associate II alongside global clinical monitoring activities.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to manage required travel of up to 75% on a regular basis
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